Resources

A. Guidance Notes
B. Biomedical Research Legislation
C. Organisation
D. Other Relevant Documents
E. Frequently Asked Questions

 

 

A. Guidance Notes

A1: Guidance Note on IRB approvals​​​​

 

B. Biomedical Research Legislation

C. Organisation

D. Other Relevant Documents

E. Frequently Asked Questions

Yes. All research conducted by NTU staff involving the use of human subjects, tissues, or personal data must be reviewed and approved by the NTU-Institutional Review Board (IRB).
All applications must reach IRB by the 1st work day of the month in order to be reviewed by the month. Status will be known by 3rd week of that month. Application must be complete to avoid any further delay.
Yes as IRB need to review all research proposal which involve human subjects.
Yes unless participation rate will be greatly affected if parental consent is being sought. E.g.: It may not be practical to seek parental consent if the research is on premarital sex. For such cases PI is to explain in detail to the parents of the subject on why parental consent is not being sought immediately after the interview/ survey is conducted. This is to repair the trust that may have been damaged or it causes there is no more than minimal risk to the subjects.

The study contains no risk to subjects. However, it is also dependent on the situation and the subject. E.g.: Seeking opinion about one’s gynae:-

  • from a mother – no risk
  • a pregnant woman – minimal risk, subject may feel distress
  • woman who is in labour – highly stress situation, vulnerable group
No. Participating students must be given the right to withdraw even after consent is given and their grades must not be in anyway impacted.
  • Risk
  • Benefit
  • Alternative (credit / treatment)
  • Confidentiality
  • Compensation for Injury
  • Whom to contact (PI and IRB)
  • Right to refuse or withdraw
Yes. You are allowed to submit the questionnaires later. The approval given by IRB will be for Phase 1.
Yes. Very often subjects may expect data which has been collected to be discarded especially containing sensitive data. Unless it is made known to subject that the data collected will be used for other purpose at the point of initial consent is given. However PI still need to inform subject that the data collected will be used in another study even if blanket approval is given. In addition, PI need to re-consent subjects if data are to be used in other unrelated study.

Yes. And the following must be stated clearly in the consent form.

  • Probability of winning
  • Mode of contacting the winner
  • The process of conducting the lucky draw must be conducted fairly.